Global Medical Device Certification Specialist
The Global Medical Device Certification Specialist plays a critical role in ensuring the compliance of medical devices with regulatory requirements. The specialist is responsible for reviewing audit packs to verify data and content for compliance with MDD 93/42 EC or MDR (EU) 2017/745. This involves verifying that audit documentation for QMS on-site as well as technical documentation assessment is in compliance with the medical device regulations and internal procedures.
In this role, you will be working closely with auditors, product assessors, and certification decision makers to ensure the smooth operation of certification processes. You will also be responsible for checking audit packs for QMS on-site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes. The successful candidate will have a strong understanding of global medical device Regulations and good analysis capacity to detect discrepancy or issues.
Main Responsibilities:
* Review audit packs to verify data and content for compliance with MDD 93/42 EC or MDR (EU) 2017/745.
* Verify audit documentation for QMS on-site as well as technical documentation assessment.
* Work closely with auditors, product assessors, and certification decision makers to ensure smooth operation of certification processes.
* Check audit packs for QMS on-site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes.
Requirements:
* Experience in a similar position in a European notified body.
* Significant work experience in the medical device field as Lead Auditor or as Product Assessor in a Notified Body.
* Detailed understanding of global medical device Regulations and good analysis capacity to detect discrepancy or issues.
* Good communication skills.
* Strong team building skills.
* Fluent in English. Other languages are a benefit.
What We Offer:
* A globally recognized and stable company in the Testing, Inspection, and Certification (TIC) industry.
* A flexible schedule and work model.
* Access to continuous learning options through SGS University and Campus.
* A multinational environment where you can collaborate with colleagues from multiple continents.
* A comprehensive benefits platform.